NCT Number: NCT02379312
Comparison of the Satiety Effect of a Very Low Energy Foam With Normal Energy Foams
To compare, in a randomized, single-blinded, cross-over study the satiety effect of a very low energy aerated beverage with normal energy aerated beverages in healthy subjects.
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About this study
The primary objective of this study is to assess if a very low energy foam has the same effect on satiety as the same volume of a reference normal energy foam, by testing for equivalence of these two foams. Treatment equivalence, is met if the 90% confidence interval (CI) of between-treatment differences in appetite AUC is within the range of -5 to +5 mm/min of the reference . Two other normal energy foams with slightly different compositions are also compared to the reference foam to test for possible effects of differences in composition (carbohydrate type, emulsifier) other than energy per se.
On each test day, volunteers will arrive at the clinic in a fasted state where they consume a standardized 250 kcal breakfast. Subjects receive one of the four test products 2.5 hours after start of breakfast and consume 400 ml of the test products with a spoon within 10 minutes. Each subject will be randomized to a treatment order according to a balanced (Williams type) design, and receive one of four test products each week for 4 weeks, separated by a one-week washout period (consumed on the same week day).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- BMI between 20 and 30 kg/m² (inclusive)
- Apparently healthy: no medical conditions which might effect study measurements (judged by study physician).
Exclusion criteria
- Dislike, allergy or intolerance to test products
- Eating disorder (measured by SCOFF questionnaire, > 2 "yes" responses)
- High or very high restrained eater measured by Three factor eating questionnaire TFEQ, restriction score > 14
- Reported medical treatment that may affect eating habits/satiety
Treatment and study plan
Normal energy aerated beverage 1
Dietary SupplementNormal energy aerated beverage 2
Dietary SupplementNormal energy aerated beverage 3
Dietary SupplementPrimary outcomes
-
Hunger and satiety questions
Time frame: Time points -155, -90, -5, 15, 30, 60, 90, 120, 150 and 180 min
Area under the time curve of hunger and satiety scores (as rated by the subjects on a Visual Analog Scale)
Secondary outcomes
-
Electronic Visual Analogue Scale (EVAS) for liking questions
Time frame: Time point 15 min
Sponsors and collaborators
Lead sponsor
Unilever R&D
Industry
Collaborators
- Eurofins Optimed
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Mar 4, 2015
- Registry last updated
- Mar 4, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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